Essure birth control was supposed to be a simple, permanent form of birth control. Yet many women have reportedly experienced extremely painful Essure complications that the manufacturer failed to warn about.

Bayer, which purchased Essure from Conceptus in 2013, allegedly knew about the side effects that the Essure coil could cause, said one woman who participated in the clinical trial for the drug.

Participant Kimberly L. joined the clinical trial for Essure birth control in 2000. Essure birth control is a small spring or coil that is inserted into the fallopian tubes. Eventually, the tubes scar over, effectively blocking pregnancy.

Essure coils were marketed as a non-surgical form of birth control that would last for the remainder of the user’s lifetime. Kimberly, however, felt that something was wrong from the instant Essure coils were inserted and eventually requested that the coils be removed. She claims, “Words can’t even describe how horrible it makes me feel.” Kimberly experienced bloating and pain among other Essure complications.

Kimberly claims that Bayer altered her medical records from the clinical study. She states, “I noticed there were things crossed out and someone else’s initials on there on quite a few things. And I consider that falsifying my documents.”

Alterations allegedly include changing Kimberly’s level of reported pain from “extreme pain” to just “pain.” The record shows that Kimberly experienced excellent comfort levels during the clinical trial, when she claims to have suffered from bloating and pain on a daily basis. 

Kimberly is upset that Essure’s former manufacturer, Conceptus, told the FDA that no woman in the study asked to have the device removed. Kimberly requested to have the coils removed from her body but, rather than remove the device, the manufacturer seems to have dropped Kimberly from the clinical trial. Curiously, the file shows Kimberly was “lost for follow up” just days after her unsuccessful request.  

Essure Lawsuits

Women have filed Essure lawsuits after experiencing painful Essure complications such as bloating, rashes, allergic reactions, excessive bleeding, organ perforation, pelvic pain, miscarriage and ectopic pregnancy.

Allegations include claims that Bayer misled the public about the safety of Essure birth control. While Kimberly, who has filed an Essure lawsuit, may have different claims than other women because she was a participant in the clinical trial, all Essure lawsuits may benefit from the knowledge that Essure’s manufacturer allegedly altered the clinical trial results.

So far, over 4,500 women have reported adverse Essure events to the FDA. Some of those aggrieved women may go further and file an Essure lawsuit against the device’s manufacturer.